BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 2212594 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-01833
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2011-01832 AND 1627487-2011-01834. THE PT (B)(6) RECEIVED HIS SCS SYSTEM, INCLUDING THREE PERCUTANEOUS LEADS, ON (B)(6) 2011 FOR LEFT LEG PAIN. IT WAS REPORTED THAT THE PT FELT STIMULATION IN THE RIBS. AN X-RAY REVEALED THAT TWO OF THE LEADS HAD MIGRATED. ON (B)(6) 2011, THE PHYSICIAN TOOK THE PT TO SURGERY. THE PHYSICIAN NOTED BLOOD IN ONE OF THE IPG PORTS AND IN ONE OF THE DUAL EXTENSION'S PORTS. IT WAS REPORTED THAT THE LEAD WHICH WAS CONNECTED TO THE IPG PORT WITH BLOOD APPEARED TO HAVE BLOOD ALONG ITS LENGTH AND A CUT IN ITS OUTER COATING. THE PHYSICIAN EXPLANTED AND REPLACED THIS LEAD; THE OTHER TWO LEADS WERE REPOSITIONED AND REMAIN IMPLANTED. THE EXPLANTED LEAD WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3224742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| SCS EXTENSION: MODEL 334X